Low Carbohydrate Portfolio or "Eco-Atkins" Diet

NCT00256516 | Completed Phase 2

• 1 other identifier: REB 05-025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Exchange of the butter, eggs, cheese and meat in the Atkins diet for soy protein foods, other vegetable proteins including gluten and vegetable fats, nuts, avocado, olive and canola oil will result in dramatic rather than modest reductions in blood lipids with weight loss. In effect this will represent an exchange of saturated fat and animal protein for healthy monounsaturated and polyunsaturated fats and vegetable proteins with significant effects on blood lipids while still encouraging weight loss.

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Keywords

Diet Therapy

Outcome Measures

Primary Outcomes (3)

• total and low-density lipoprotein (LDL) cholesterol

• LDL:HDL cholesterol ratio

• weight reduction

Secondary Outcomes (4)

• blood pressure

• high-density lipoprotein (HDL) cholesterol

• HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size

• glucose, insulin and measurements of oxidative stress

Study Arms (2)

Eco-Atkins diet

EXPERIMENTAL

Other: Eco-Atkins diet (high vegetable protein and vegetable fat)

NCEP diet

ACTIVE COMPARATOR

Other: NCEP diet

Interventions

Eco-Atkins diet (high vegetable protein and vegetable fat) OTHER

Eco-Atkins diet

NCEP diet OTHER

NCEP diet

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and postmenopausal women between the age of 21 and 70
• Body mass index \> 27 kg/m2 and whose body weight has remained constant over the last 6 months preceding the onset of the study.
• Fasting plasma LDL cholesterol concentration \> 3.4 mmol/L at diagnosis.
• Treated by diet.
• Alcohol intake \< 14 drinks per week.
• Fasting plasma triglyceride concentration \> 0.5 mmol/L and \< 5.0 mmol/L.
• Living within a 40 km radius of St. Michael's Hospital or the University of Toronto.

You may not qualify if:

• Premenopausal women due to the fluctuation of blood lipids during the menstrual cycle.
• Taking lipid lowering medications. (However, with their physician's approval those who wish to join but are already taking cholesterol-lowering medications may join the study providing the medications are stopped for at least two weeks before starting the study and throughout the study.)
• Evidence of major cardiovascular event (stroke or myocardial infarction) within the past 6 months.
• Positive molecular diagnosis of familial hypercholesterolemia.
• Secondary causes of hypercholesterolemia (hypothyroidism, renal or liver disease).
• Diabetes
• Uncontrolled high blood pressure (\> 140/90mmHg).
• Major disability or disorder such as liver disease, renal failure or cancer or with major surgery \< 6 months prior to randomization.
• LDL-C levels below 3.0 mmol/L on a Step 2 diet prior to randomization.
• Postmenopausal women on hormone replacement therapy
• Smokers
• Patients with food allergies.
• Patients with a history of any form of cancer or are considered at high risk for cancer. However, if such patients wish to join the study, we, the researchers, would like them to obtain the approval of their oncologist or responsible physician prior to enrollment in the study.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (3)

• Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Greaves KA, Paul G, Singer W. The effect of a plant-based low-carbohydrate ("Eco-Atkins") diet on body weight and blood lipid concentrations in hyperlipidemic subjects. Arch Intern Med. 2009 Jun 8;169(11):1046-54. doi: 10.1001/archinternmed.2009.115.

  PMID: 19506174 RESULT

• Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Paul G, Mukherjea R, Krul ES, Singer W. Effect of a 6-month vegan low-carbohydrate ('Eco-Atkins') diet on cardiovascular risk factors and body weight in hyperlipidaemic adults: a randomised controlled trial. BMJ Open. 2014 Feb 5;4(2):e003505. doi: 10.1136/bmjopen-2013-003505.

  PMID: 24500611 DERIVED

• Wong JM, Kendall CW, Marchie A, Liu Z, Vidgen E, Holmes C, Jackson CJ, Josse RG, Pencharz PB, Rao AV, Vuksan V, Singer W, Jenkins DJ. Equol status and blood lipid profile in hyperlipidemia after consumption of diets containing soy foods. Am J Clin Nutr. 2012 Mar;95(3):564-71. doi: 10.3945/ajcn.111.017418. Epub 2012 Feb 1.

  PMID: 22301925 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David JA Jenkins, MD, PhD, DSc

  University of Toronto and St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: April 1, 2005
• Study Completion: December 1, 2006
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

CA (1)